BEUDAMED
    FDA Adverse Event Other Summary report: N

    SP D-VIEW 4" LIGHT PANEL

    MDR report key: 396403 · Received May 29, 2002

    Report

    Report Number
    1221601-2002-00013
    Event Type
    Other
    Date Received
    May 29, 2002
    Date of Event
    April 30, 2002
    Report Date
    May 28, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GER
    Product Code
    FDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ALLEGEDLY BURNED WHEN THE RETRACTOR WITH LIGHT PANEL WAS PLACED ON THE PATIENT DURING THE PROCEDURE. THE CUSTOMER ALLEGED THE INSTRUMENT WAS USED LESS THAN ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SP D-VIEW 4" LIGHT PANEL LIGHT PANEL FDG GENZYME BIOSURGERY A DIVISION OF GER 88-1006 524223

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other